Comparing CT-P44 and Darzalex Faspro with lenalidomide and dexamethasone in patients with refractory or relapsed multiple myeloma

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What is this study about?

This clinical trial focuses on treating patients with Refractory or Relapsed Multiple Myeloma, a type of blood cancer that returns after previous treatment or does not respond to current treatments. The study compares two medications: CT-P44 and Darzalex Faspro, both containing the active substance daratumumab. These medications will be used in combination with two other drugs: lenalidomide and dexamethasone.

The purpose of this study is to compare how well CT-P44 works compared to Darzalex Faspro, and how the body processes these medications. Both medications are given through subcutaneous injection, which means they are injected under the skin. The study is designed as a double-blind trial, meaning neither the patients nor the healthcare providers know which medication is being given.

During the study, participants will receive treatment for up to 104 weeks. The medications will be administered regularly according to a specific schedule, with a maximum daily dose of 1800 mg. Patients will be monitored throughout the treatment period to evaluate how well the medications work and to check for any side effects.

1 Initial treatment phase

You will receive a combination of medications through subcutaneous injection (injection under the skin) and other medications

The treatment combines daratumumab with two additional medications: lenalidomide and dexamethasone

The treatment will be administered in cycles, with regular monitoring of your response

2 First dose evaluation

During the first week of treatment, your body’s response to the medication will be closely monitored

Medical tests will be performed to measure how your body processes the medication

3 Ongoing treatment phase

You will continue receiving treatment for up to 9 doses

Between weeks 8 and 10, additional tests will be conducted to measure how your body processes the medication

Your response to the treatment will be evaluated regularly throughout this period

4 24-week assessment

Your overall response to the treatment will be evaluated up to week 24

The medical team will assess the effectiveness of the treatment based on standard criteria for multiple myeloma

This assessment will determine how well you have responded to the treatment

5 Extended monitoring

The study will continue with regular monitoring of your condition

The total duration of the study extends until October 31, 2029

Regular assessments will continue throughout this period to monitor your health status

Who Can Join the Study?

Must be 18 years of age or older
Must have been diagnosed with multiple myeloma (a type of blood cancer that affects plasma cells)
Must have relapsed or refractory disease (meaning the cancer has returned after treatment or did not respond well to previous treatments)
Must have shown a positive response (partial response or better) to at least one previous treatment according to established medical criteria
Must have experienced disease progression (worsening of the condition) during or after their most recent treatment
Must have received at least 1 but no more than 3 previous treatments for multiple myeloma
Both men and women can participate in the study

Who Cannot Join the Study?

Prior treatment with daratumumab (a type of targeted therapy for multiple myeloma) or other anti-CD38 medications
Active plasma cell leukemia (an aggressive form of blood cancer)
History of severe allergic reactions to similar medications
Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV
Major surgery within 2 weeks before starting the study
Participation in other clinical trials within 4 weeks before this study
Significant heart problems, including heart failure or recent heart attack
Severe liver or kidney problems
Active or untreated cancer other than multiple myeloma
Pregnancy or breastfeeding
Unable to use effective birth control methods during the study
Mental conditions that could interfere with following study procedures
Stem cell transplant (a procedure to replace damaged bone marrow) within 100 days before the study
Use of other experimental treatments within 4 weeks before the study

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
Nwqexdsu Ioonlreb Oszsqlgyt Izh Migzm Srtpehwsxdwnluffrghtjojgbseb Imtagcex Bzpenott	Cracow	Poland
Inphahio Cgtdae Dtqvkxnoupxlrylai	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	10.07.2025
Spain	Recruiting	10.07.2025

Trial locations

Investigated drugs:

CT-P44 is an investigational medication being tested as a biosimilar to Darzalex Faspro. It is designed to treat patients with multiple myeloma, a type of blood cancer. It is given as an injection under the skin (subcutaneous injection).

Darzalex Faspro (daratumumab) is an approved medication used to treat multiple myeloma. It works by targeting specific proteins on cancer cells to help the immune system fight the cancer. It is administered as an injection under the skin.

Lenalidomide is a medication that helps fight multiple myeloma by working in several ways. It helps boost the immune system, blocks the growth of cancer cells, and prevents the formation of new blood vessels that feed the cancer.

Dexamethasone is a corticosteroid medication that helps reduce inflammation in the body. In multiple myeloma treatment, it is often used in combination with other medications to make them work more effectively and help manage certain side effects.

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that normally produce antibodies to fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells produce large amounts of abnormal proteins while crowding out healthy blood cells. The disease can weaken bones, reduce immune function, and interfere with the production of normal blood cells. Multiple myeloma typically progresses through cycles of active disease and remission.

Trial ID:

2024-518588-36-00

Protocol code:

CT-P44 3.1

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparing CT-P44 and Darzalex Faspro with lenalidomide and dexamethasone in patients with refractory or relapsed multiple myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?